JPRN-jRCT2080220970未知1 期
A Phase 1, Multiple-Dose Study of the Safety, Tolerability, and Pharmacokinetics of TAK-700 in Hormone Therapy-Resistant Prostate Cancer Subjects
适应症
试验速览
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- Male
入选标准
- •Inclusion criteria include the following:
- •1. Japanese patients histologically or cytologically diagnosed with prostate cancer
- •2. Undergone orchiectomy or receiving hormone therapy with an LH-RH agonist, with serum testosterone < 0.5 ng/mL at screening
- •3. PSA => 2 ng/mL at screening
- •4. Increase from nadir PSA in two or more successive measurements before screening* (The measurements must be made at least one week apart at the same laboratory.)
- •*Even if the patient's PSA level at the second measurement is not higher than the increased PSA level at the first measurement, he is regarded to meet this criterion if his PSA level at the third measurement is higher than the first increased PSA level.
- •5. No use of any antiandrogens during a period specified below:
- •1) Bicalutamide: => 6 weeks (42 days) prior to the first dose of the investigational product
- •2) Other antiandrogens: => 4 weeks (28 days) prior to the first dose of the investigational product
- •6. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 to 2 at screening
- •7. Judged to have no clinical problems based on physical examination, echocardiography, ECG, and chest X-ray at screening.
- •8. Left ventricular ejection fraction (LVEF) at screening at or above the lower limit of the institutional normal range.
- •9. Cardiac enzymes (creatinine kinase-MB [CK-MB] and cardiac troponin T) at screening within the institutional normal range.
- •And the others.
排除标准
- •Exclusion criteria include the following:
- •1. Prior chemotherapy
- •2. Prior Estramustine therapy
- •3. Prior 125I seed implants brachytherapy
- •4. Use of any of the following therapies for prostate cancer within 16 weeks (112 days) prior to the first dose of the investigational product: high intensity focused ultrasound, prostatectomy, radiation therapy (except 125I seed implants brachytherapy)
- •5. Use of any of the following within 4 weeks (28 days) prior to the first dose of the investigational product: androgen preparations, estrogen preparations (except estramustine), 5 alpha-reductase inhibitors (i.e., finasteride, dutasteride), zoledronate, Chinese herbal medicines including Saw Palmetto, and supplements
- •6. Use of any of the following within 4 weeks (28 days) prior to the first dose of the investigational product: spironolactone and corticosteroids (with the exception of inhaled and topical steroids)
- •7. Use of any prior therapy for prostate cancer (e.g., ketoconazole [with the exception of topical formulations]) within 4 weeks (28 days) prior to the first dose of the investigational product
- •8. Active multiple primary cancers (synchronous multiple primary cancers, or metachronous multiple primary cancers with a disease-free period of 5 years or less).
- •9. Past or concomitant adrenal insufficiency
- •10. History of any condition that may interfere with absorption of the investigational product and thus affect the pharmacokinetic evaluation (e.g., gastrectomy, extensive resection of the small intestine)
- •11. History of any of the following within 12 months (364 days) prior to enrollment in the study: myocardial infarction, symptomatic ischaemic heart disease, cardiac arrhythmias, thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or other cardiac conditions (e.g., pericardial effusion and restrictive cardiomyopathy)
- •12. Past or concomitant congestive heart failure of New York Heart Association (NYHA) Class II or greater
- •13. Concurrent presence of poorly controlled or refractory hypertension, as defined by the Guidelines for the Management of Hypertension, 2009.
- •And the others
研究者
相似试验
尚未招募
不适用
GEN-001 multiple dose phase 1 studyKCT0006311Jeonbuk National University Hospital12
招募中
1 期
CAPRISA 012BHIV/AIDSPACTR202003767867253CAPRISA76
已完成
1 期
Clinical trial to evaluate safety, tolerability and pharmacokinetic of herbal (ICB-014-A002) capsule in healthy adult volunteers.CTRI/2018/01/011259Indian Institute of Integrative Medicine Council of Scientific Industrial Research38
未知
1 期
A Phase 1, Repeat Dose Study to Evaluate the Safety, Tolerability, Biological Activity, and Pharmacokinetics of ND-L02-s0201 Injection in Japanese Subjects with Advanced Hepatic Fibrosis (METAVIR F3-4)Advanced Hepatic FibrosisJPRN-jRCT2080222907ITTO DENKO CORPORATIO9
进行中（未招募）
1 期
A clinical gene therapy study with hematopoietic stem cells for the treatment of patients suffering from a plasma cell tumor.Multiple myeloma in early relapse after intensive front line therapyMedDRA version: 20.0Level: LLTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 100000004864EUCTR2018-001741-14-ITOSPEDALE SAN RAFFAELE3